FDA is working hard on expanded access program for patients with non-tuberculous mycobacterial (NTM) lung infections; there is no approved drug for the condition in part because of the difficulty in defining trial endpoints.
An FDA patient-focused meeting on non-tuberculous mycobacterial (NTM) lung infections illustrated the difficulties companies face in developing new antibiotics. The hurdles are particularly high for NTM, a rare condition in which response to treatment varies based on the infecting organism and underlying disease.
There is no approved treatment for NTM lung infections and patients try to manage the disease with a cocktail of antibiotics. But given the side effects and variable efficacy of...
Acadia’s Nuplazid for hallucinations and delusions associated with Parkinson’s disease psychosis appears safe from generic competition until well into the next decade, following a favorable infringement and validity decision by a US district court.
The US FDA ended efforts to regulate lab-developed tests as medical devices for now when it did not appeal a decision from the Eastern District of Texas that tossed out the agency's final rule.
Two pharmacies, a medical spa and a telehealth company voluntarily removed efficacy, safety and quality claims for compounded GLP-1 products after innovator companies filed challenges with the National Advertising Division.
The remarks from the new CBER director suggest Prasad will not be involved in most product-specific decisions.
A UK research team has used artificial intelligence to find new treatments for cancer using existing US Food and Drug Administration-approved medicines that are not normally not used for the disease.
The US Medicare Payment Advisory Commission worries that Medicare prescription drug market trends may cause the stand-alone plan portion of the program to “wither away,” which could take the traditional fee-for-service side of Medicare with it.
The Clinical Trials Access Collaborative (CTAC) will build on a pilot program's work to bolster community-based clinical research infrastructure so "anyone who wants to participate in clinical trials can and do it closer to home,” CEO Tesheia Harris said in an interview.
